Field of the Invention
This invention relates to a low cost blood collection set and, more particularly, to an integrated low cost blood collection set and package wherein the package forms the holder for manipulation of the needle cannula and also forms the shield for enclosing the needle cannula after use.
Description of Related Art
Blood collection tubes are commonly used by doctors, nurses, and other medical personnel to draw a sample of a body fluid from a patient or to receive a fluid sample from another vessel. Such tubes are ordinarily evacuated, and include a pierceable closure. During one typical use of a blood collection tube, one end, such as the patient end, of a double-ended needle cannula is used to pierce a vein. The evacuated blood collection tube is then urged towards the second end or non-patient end, of the double-ended needle cannula until its closure is pierced. Blood is thereby drawn into the tube.
The double-ended needle cannula is typically mounted to a hub to form a double-ended needle assembly. This double-ended needle assembly is ordinarily mounted to a holder having a tubular body. The blood collection tube is inserted within the tubular body in order to engage the second or non-patient end of the needle cannula. One example of a needle holder assembly and blood collection tube is shown in U.S. Pat. No. 6,017,317, owned by the assignee of the present invention, the entirety of which is hereby incorporated by reference. U.S. Pat. Nos. 4,991,601 and 4,150,666 also disclose various blood collection tubes and/or holders for such tubes.
The double-ended needle assembly and holder are typically packaged in a sterile blister pack. The medical practitioner then removes the holder and needle assembly, inserts the first end or patient end of the needle cannula into a patient, and then inserts a fluid collection tube, such as a vacuum tube, into the holder and into contact with the second or non-patient end of the needle cannula to collect the fluid sample. Safe fluid collection practices include use of a needle shield to cover the needle after use and to allow for proper and sanitary disposal thereof. This shield can be associated with the needle holder or can be a separate member.
Manufacturing costs and packaging of these various members of the fluid collection set can be costly, so that use of the fluid collection set in economically disadvantaged communities is not possible. Oftentimes, the components are separately manufactured and assembled to form the fluid collection set. After assembly, a package is thermoformed about the contours of the holder, needle assembly, and/or the shield to form a sterile blister pack. As a cost-saving measure, these economically disadvantaged communities may attempt to reuse the holder, which could post a health risk to the medical practitioner and/or patient. Also, cross-contamination of a fluid sample could occur due to the reuse of the holder. As another cost-saving measure, a needle shield that may not be used for proper disposal may be eliminated from the collection set.
Accordingly, there is a need in the art that eliminates the need for the manufacturing of these multiple components of the blood collection set and that eliminates the assembly time associated therewith prior to packaging. There is also a need in the art which would prevent reuse of the needle holder and would eliminate the additional costs associated with providing a needle shield.